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《China Medical Equipment》 2015-01
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Comparative analysis of FDA software submission guidance

PENG Liang;LIU Xiao-yan;Center for Medical Device Evaluation of CFDA;  
Objective: The FDA regulation requirements for medical device software are relatively mature and systematic, and the research on the FDA regulation thinking of medical device software helps to promote the regulation work of the medical device software in our country. Methods: Based on the comparison of the 1998 edition and 2005 edition FDA software submission guidance, the trend of the FDA regulation requirements for medical device software was analyzed, and then its regulation thinking was discussed according to other current effective software-related guidance. Results: FDA integrally improves the submission requirements for all medical device software, especially for the minor Level of Concern software, and simplifies the requirements for design specification, verification and validation, but strengthens the requirements for traceability analysis and revision history. Conclusion: The regulation work of the medical device software in our country needs to fully consider the particularity of the medical device software, strengthen the audit of software quality management system, implement the software traceability analysis, and determine the regulation requirements for software change.
【Fund】: 国家科技支撑计划(2012BAI22B00)“医用软件生命周期质控和成品检测评价规范研究”
【CateGory Index】: R197.39
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